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Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02183363
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF IIb

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1356 - Tablet TFII Drug: BI 1356 - Tablet iFF Drug: BI 1356 - Tablet TFIIb Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability of BI 1356 After Single Oral Administration of 5 mg BI 1356 Given as Tablet Formulation TF IIb Relative to Tablet Formulation TF II and Tablet Formulation iFF in Healthy Male Volunteers (an Open Label, Randomised, Single-dose, Three-way Crossover Study)
Study Start Date : February 2007
Actual Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: BI 1356 - Tablet TFII Drug: BI 1356 - Tablet TFII
Drug: BI 1356 - Tablet iFF
Drug: BI 1356 - Tablet TFIIb
Experimental: BI 1356 - Tablet iFF Drug: BI 1356 - Tablet TFII
Drug: BI 1356 - Tablet iFF
Drug: BI 1356 - Tablet TFIIb
Active Comparator: BI 1356 - Tablet TFIIb Drug: BI 1356 - Tablet TFII
Drug: BI 1356 - Tablet iFF
Drug: BI 1356 - Tablet TFIIb



Primary Outcome Measures :
  1. AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours) [ Time Frame: predose, up to 24 hours ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: predose, up to 264 hours ]
  2. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: predose, up to 264 hours ]
  3. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: predose, up to 264 hours ]
  4. AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2) [ Time Frame: predose, up to 264 hours ]
  5. C24 (plasma concentration of the analyte 24 hours after dosing) [ Time Frame: predose, up to 264 hours ]
  6. tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: predose, up to 264 hours ]
  7. λz (terminal rate constant in plasma) [ Time Frame: predose, up to 264 hours ]
  8. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: predose, up to 264 hours ]
  9. MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: predose, up to 264 hours ]
  10. CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: predose, up to 264 hours ]
  11. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: predose, up to 264 hours ]
  12. Changes in Dipeptidyl-peptidase-IV (DPP-IV) activity in plasma [ Time Frame: predose, up to 264 hours ]
  13. Changes in plasma glucose levels [ Time Frame: predose, up to 264 hours ]
  14. Number of patients with adverse events [ Time Frame: up to 18 days following last drug administration ]
  15. Number of patients with abnormal findings in physical examination [ Time Frame: up to 18 days following last drug administration ]
  16. Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR)) [ Time Frame: up to 18 days following last drug administration ]
  17. Number of patients with abnormal changes 12-lead ECG (electrocardiogram) [ Time Frame: up to 18 days following last drug administration ]
  18. Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to 18 days following last drug administration ]
  19. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 18 days following last drug administration ]


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs, Blood Pressure (BP), Pulse Rate (PR), 12-lead Electrocardiogram (ECG), clinical laboratory tests

    • No findings deviating from normal and of clinical relevance
    • No evidence of a clinically relevant concomitant disease
  • Age ≥21 and Age ≤55 years
  • BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of study centre

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183363    
Other Study ID Numbers: 1218.25
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action